MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAF-T-INTIMA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 383313

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

Event Description

When placing iv, sliding out needle via stylet, needle pulled out of stylet safety system exposing needle, no harm done.No needle stick to staff.

• Brand Name: BD SAF-T-INTIMA
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 16768325
• MDR Text Key: 313579698
• Report Number: 16768325
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383313
• Device Catalogue Number: 383313
• Device Lot Number: 2146202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other